Clinical Trial: Tocilizumab Effect iN pOlymyalgia Rheumatica

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Open 24 Weeks Study to Evaluate Effect and Safety of Tocilizumab as the First Line Therapy in Subjects With Polymyalgia Rheumatica (PMR)

Brief Summary:

Phase 1:

Patients are treated with infusions of Tocilizumab (TCZ) for 3 months. Clinical evaluation is performed using PMR-AS.

The PMR-AS is computed by summing the 5 variables after multiplying by 0.1 for weighting purposes: PMR-AS (activity scale = AS) = C reactive protein (CRP) (mg/dl) + patient scale (VASp) (0-10 scale) + physician scale (VASph) (0-10 scale) + morning stiffness(MST) [min]×0.1) + elevation of upper limbs (EUL) (0-3 scale).

At the end of the phase 1,the patients stop TCZ and entered in phase 2 at week 12.

Phase 2:

All the patients are included in the phase 2 and treated with glucocorticoid (GC)for 3 months. Two arms are possible according to the PMR-AS. Either the classical GC treatment (0.3mg/kg), either a low dose group of GC(0.15mg/kg) .


Detailed Summary:
Sponsor: University Hospital, Brest

Current Primary Outcome: Efficacy at W12 [ Time Frame: 12 Weeks ]

PMR-AS at week 12


Original Primary Outcome: Same as current

Current Secondary Outcome: Safety and efficacy during the study [ Time Frame: Week 2,4,8,12,16,20 and 24 ]

  • To maintain low disease activity (PMR-AS) in the low corticosteroid dose group from W12 to W24
  • On the inflammatory changes (synovitis, myositis, tenosynovitis aund bursitis) between baseline, W2 and 12 visualize by ultrasonography, MRI and Tep-Scan.
  • On sparing corticosteroid, with the comparison of the cumulative corticosteroid dosage beetwen the two groups of patients in the phase 2, W12 to 24.
  • On the circulating serum cytokines and immunoregulators (IL-6, IL-1, BLyS/BAFF, IL-6 receptor, gp130) and B cells receptors and on the phenotype of circulating T- and B-cells between baseline and W4 and 12 On inflammatory parameters (CRP and ESR) between baseline and W 2,4,8,12,16,20 and 24
  • On the quality of life of patients between baseline and W 4,12,16, 20 and 24
  • To evaluate the side-effects in relation to the use of Tocilizumab treatment. [ Time Frame: After first, second and third treatment and during follow up ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Brest

Dates:
Date Received: September 17, 2012
Date Started: July 2012
Date Completion:
Last Updated: February 10, 2015
Last Verified: January 2015